BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 5CM DIAPHYSEAL SEGMENT

    MDR report key: 3960187 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06434
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. COMPONENT FRACTURE IS ADDRESSED IN THE I/O RISK TABLE AND DEEMED WITHIN RISK TOLERANCE. MANUFACTURING HISTORY SUGGESTS THAT PRODUCT LEFT BIOMET CONFORMING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE HIP PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO IMPLANT FRACTURE OF THE DIAPHYSEAL SEGMENT; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE HIP PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED DIAPHYSEAL SEGMENT. THE DIAPHYSEAL SEGMENT AND THE PROXIMAL FEMORAL COMPONENT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438204 OSS 5CM DIAPHYSEAL SEGMENT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 518040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R